Panels › Hematology › Product code LCO · Class 2
Platelet Factor 4 Radioimmunoassay
Regulation 864.7695
0510(k)s in 12 months (13 all time)
4recalls in 12 months (13 all time)
13recalls that name a 510(k)
Top companies in LCO
| Company | 510(k)s | Recalls |
|---|---|---|
| Hyphen Biomed | 1 | 5 |
| Genetic Testing Institute | 3 | 2 |
| Instrumentation Laboratory CO | 2 | 2 |
| Aniara Diagnostica LLC | 0 | 3 |
| Diagnostica Stago, Inc. | 1 | 1 |
| Immucor Gti Diagnostics, Inc. | 2 | 0 |
| Akers Laboratories, Inc. | 1 | 0 |
| American Bioproducts Co. | 1 | 0 |
| Behring Diagnostics, Inc. | 1 | 0 |
| Instrumentation Laboratory (IL) Co. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only) Open, Classified |
LCO | K170854 |
| Oct 10, 2026 | Instrumentation Laboratory HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009800127. in vitro diagnostic Open, Classified |
LCO | K170854 |
| May 12, 2026 | Aniara Diagnostica LLC ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A Open, Classified |
LCO | K071255 |
| Jan 14, 2026 | Diagnostica Stago, Inc. Asserachrom HPIA.
Model/Catalog Number: 00615.
The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated Open, Classified |
LCO | K003767 |
| Jul 19, 2019 | Aniara Diagnostica LLC ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use. Terminated |
LCO | K071255 |
| Jul 19, 2019 | Aniara Diagnostica LLC ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use. Terminated |
LCO | K071255 |
| Mar 15, 2018 | Hyphen BioMed ZYMUTEST HIA MonoStrip IgGAM.
Model Number: RK041D.
Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests. Terminated |
LCO | K071255 |
| Mar 15, 2018 | Hyphen BioMed ZYMUTEST HIA IgGAM.
Model Number: RK040D.
Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests. Terminated |
LCO | K071255 |
| Feb 5, 2018 | Hyphen BioMed ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, Terminated |
LCO | K071255 |
| Feb 5, 2018 | Hyphen BioMed ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratorie Terminated |
LCO | K071255 |
| Feb 5, 2018 | Hyphen BioMed ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical labo Terminated |
LCO | K071255 |
| Jan 20, 2015 | Genetic Testing Institute,inc PF4 Concentrated Wash (10x), REF 403624, packaged in the following assay kits: 1. ImmucorGamma LIFECODES PF4 IgG (catalog numbers HAT13G, HAT45G) and
2. ImmucorGamma LIFECODES PF4 Enhanced (catalo Terminated |
LCO | K053559 |
| Mar 28, 2013 | Genetic Testing Institute,inc Gen-Probe LIFECODES PF4 Enhanced assay, Catalog No. X-HAT45
GTI PF4 Enhanced is designed as a solid phase enzyme-linked immunosorbent assay (ELISA). Terminated |
LCO | K053559 |
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